NCT05543954

Brief Summary

Based on the high expression of specific receptors on the surface of diseased tissues and neovascularization, noninvasive targeted molecular imaging can be used to visualize lesions in vitro by combining specific ligands labeled with short half-life isotopes. Lung cancer tissues express fibroblast activating protein FAP, and also have high expression of integrin αVβ3 receptor on the surface of blood vessels. In this study, a novel dual-target imaging agent 68Ga-FAPI-RGD was used for PET/CT imaging of lung cancer.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Sep 2022

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 3, 2022

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2022

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

July 5, 2024

Status Verified

July 1, 2024

Enrollment Period

3.3 years

First QC Date

September 13, 2022

Last Update Submit

July 3, 2024

Conditions

Lung Neoplasms

Outcome Measures

Primary Outcomes (3)

  • Diagnostic performance1

    comparing the SUV and number of lung cancer or metastasis detected by 68Ga-FAPI-RGD and 18F-FDG PET/CT

    through study completion, an average of 1 year

  • Diagnostic performance2

    comparing the SUV and number of lung cancer or metastasis detected by 68Ga-FAPI-RGD and 68Ga-FAPI PET/CT

    through study completion, an average of 1 year

  • Diagnostic performance3

    comparing the SUV and number of lung cancer or metastasis detected by 68Ga-FAPI-RGD and 68Ga-RGD PET/CT

    through study completion, an average of 1 year

Secondary Outcomes (2)

  • The dosimetry of 68Ga-FAPI-RGD

    through study completion, an average of 1 year

  • 68Ga-FAPI-RGD uptake at different time points

    through study completion, an average of 1 year

Study Arms (3)

68Ga-FAPI-RGD and 18F-FDG PET/ CT scan

EXPERIMENTAL

Within 2 week, each patient underwent PET/CT scan after intravenous administration of 68Ga-FAPI-RGD and 18F-FDG, respectively.

Drug: 68Ga-FAPI-RGDDrug: 18F-FDG

68Ga-FAPI-RGD and 68Ga-FAPI PET/ CT scan

EXPERIMENTAL

Within 2 week, each patient underwent PET/CT scan after intravenous administration of 68Ga-FAPI-RGD and 68Ga-FAPI, respectively.

Drug: 68Ga-FAPI-RGDDrug: 68Ga-FAPI

68Ga-FAPI-RGD and 68Ga-RGD PET/ CT scan

EXPERIMENTAL

Within 2 week, each patient underwent PET/CT scan after intravenous administration of 68Ga-FAPI-RGD and 68Ga-RGD, respectively.

Drug: 68Ga-FAPI-RGDDrug: 68Ga-RGD

Interventions

68Ga-FAPI-RGDDRUG

Intravenous injection of 68Ga-FAPI-RGD with a dosage of approximately 1.8-2.2 MBq (0.05-0.06 mCi)/kg.

Also known as: 68Ga-FAPI-RGD injection
68Ga-FAPI-RGD and 18F-FDG PET/ CT scan68Ga-FAPI-RGD and 68Ga-FAPI PET/ CT scan68Ga-FAPI-RGD and 68Ga-RGD PET/ CT scan
18F-FDGDRUG

Intravenous injection of 18F-FDG with a dosage of approximately 3.7-5.55 MBq (0.1-0.15 mCi)/kg.

Also known as: 18F-FDG injection
68Ga-FAPI-RGD and 18F-FDG PET/ CT scan
68Ga-FAPIDRUG

Intravenous injection of 68Ga-FAPI with a dosage of approximately 1.8-2.2 MBq (0.05-0.06 mCi)/kg.

Also known as: 68Ga-FAPI injection
68Ga-FAPI-RGD and 68Ga-FAPI PET/ CT scan
68Ga-RGDDRUG

Intravenous injection of 68Ga-RGD with a dosage of approximately 1.8-2.2 MBq (0.05-0.06 mCi)/kg.

Also known as: 68Ga-RGD injection
68Ga-FAPI-RGD and 68Ga-RGD PET/ CT scan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with confirmed or suspected lung cancer;
  • Ga-FAPI-RGD and 18F-FDG(or 68Ga-FAPI or 68Ga-RGD) PET/CT within 2 week;
  • signed written consent.

You may not qualify if:

  • pregnancy;
  • breastfeeding;
  • any medical condition that in the opinion of the investigator may significantly interfere with study compliance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Fluorodeoxyglucose F1868Ga-FAPI

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

DeoxyglucoseDeoxy SugarsCarbohydrates

Study Officials

  • Zhaohui Zhu, MD,PHD

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhaohui Zhu, MD,PHD

CONTACT

86+1361109375213611093752@163.com

Rongxi Wang

CONTACT

86+19800370331pumch_jacobwong@163.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2022

First Posted

September 16, 2022

Study Start

September 3, 2022

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

July 5, 2024

Record last verified: 2024-07

Locations

CN(1)